COVID-19NCT04435275
Virtual Assistant for COVID-19 PPE
A study testing Virtual Assistant first, then Human Coach and Human Coach first, then Virtual Assistant in people with COVID-19, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Virtual Assistant first, then Human Coach and Human Coach first, then Virtual Assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2021to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only anesthesia attending staff are allowed in the phase 1 study.
- Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.
Who cannot join
- Unwillingness to enter the study for phase 1 or phase 2.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, ON M5T 2S8
Rongyu Jin, rongyu.jin@uhn.ca
About this study
Official title: Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety
The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures.
Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device.
A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).
- Conditions
- COVID-19
- Being tested
- Virtual Assistant first, then Human Coach, Human Coach first, then Virtual Assistant
- Keywords
- PPE adherence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Assistant first, then Human CoachOther
Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).
Human Coach first, then Virtual AssistantOther
instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).
| Study group | Role | What they receive |
|---|---|---|
| Donning PPE using VA then doffing PPE using HC | Active comparator | Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing. Receives: Other: Virtual Assistant first, then Human Coach |
| Donning PPE using HC then doffing PPE using VA | Active comparator | Study subjects will receive HC guidance for donning first, then VA guidance for doffing. Receives: Other: Human Coach first, then Virtual Assistant |
| Intubation using VA then extubation using HC; | Active comparator | Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure Receives: Other: Virtual Assistant first, then Human Coach |
| Intubation using HC then extubation using VA | Active comparator | Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure Receives: Other: Human Coach first, then Virtual Assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of healthcare workers
Errors occurred during donning of PPE measured by procedure checklist
Measured: 0- 30mins during donning
performance of healthcare workers
Errors occurred during doffing of PPE measured by procedure checklist
Measured: 0- 30mins during doffing
performance of healthcare workers
Errors occurred during intubation measured by procedure checklist
Measured: 0- 30mins during intubation
performance of healthcare workers
Errors occurred during extubation measured by procedure checklist
Measured: 0- 30mins during extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start2 Jan 2021
- Primary completion31 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435275
- Sponsor's protocol ID
- 20-5399
- Status last verified
- May 2020
- First submitted
- 9 Jun 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety
- ClinicalTrials.gov ID
- NCT04435275
- Acronym / sponsor ID
- 20-5399
- Conditions
- COVID-19
- Keywords
- PPE adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures.
Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device.
A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Donning PPE using VA then doffing PPE using HC | Active comparator | Other: Virtual Assistant first, then Human CoachStudy subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing. |
| Donning PPE using HC then doffing PPE using VA | Active comparator | Other: Human Coach first, then Virtual AssistantStudy subjects will receive HC guidance for donning first, then VA guidance for doffing. |
| Intubation using VA then extubation using HC; | Active comparator | Other: Virtual Assistant first, then Human CoachStudy subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure |
| Intubation using HC then extubation using VA | Active comparator | Other: Human Coach first, then Virtual AssistantStudy subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Only anesthesia attending staff are allowed in the phase 1 study.
- Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.
Key exclusion criteria (1 listed)
- Unwillingness to enter the study for phase 1 or phase 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Assistant first, then Human CoachInstructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach). | Other | Donning PPE using VA then doffing PPE using HC, Intubation using VA then extubation using HC; |
| Human Coach first, then Virtual Assistantinstructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach). | Other | Donning PPE using HC then doffing PPE using VA, Intubation using HC then extubation using VA |
Primary outcome
performance of healthcare workers
Time frame: 0- 30mins during donning
Errors occurred during donning of PPE measured by procedure checklist
performance of healthcare workers
Time frame: 0- 30mins during doffing
Errors occurred during doffing of PPE measured by procedure checklist
performance of healthcare workers
Time frame: 0- 30mins during intubation
Errors occurred during intubation measured by procedure checklist
performance of healthcare workers
Time frame: 0- 30mins during extubation
Errors occurred during extubation measured by procedure checklist
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Assistant first, then Human Coach and Human Coach first, then Virtual Assistant in people with COVID-19, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyu ( Cindy) Jin (416-603-5800 ext. 2016, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of healthcare workers (time frame: 0- 30mins during donning). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.